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Latest / Medical Device Global Market Access

Unlocking Global Markets with the New Health Software Security Standard

This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to securing health software, and its growing importance for regulatory approval in key global markets like the EU, US, and Japan. Manufacturers will learn what the standard requires and why compliance is no longer optional but a strategic advantage. Key Questions: • What is IEC 81001-5-1 and why was it created? • How does this standard change the approach to software development and maintenance? • Does this standard apply only to medical…

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